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Welcome Empire SMTA Chapter
High Reliability in an EMS World 4/23/13
Mark Talmadge & Mark Northrup
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markets
Our Strategy – “High Reliability”
Agenda:
1. What is High Reliability?
2. Avenues to achieve High Reliability?
3. High Reliability as it relates to End Markets
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Medical,
Military, Aerospace, Defense & Space,
Industrial
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
IEC Operating Units Overview
Customer
Customer
Newark, NY
Rochester, NY
Albuquerque, NM
Bell Gardens, CA
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
What is High Reliability?
 Definition –
– The quality or state of being reliable
– The extent to which an experiment, test, or measuring
procedure yields the same results on repeated trials
– Reliance on and confidence in the truth, worth, reliability,
of a person or thing
– The assurance that a product will perform as designed for
an extended period of time with out failure
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Avenues to achieve High Reliability?
 Best in class people, processes, and procedures
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Effective Quality System
Education, and training of personnel involved / Focused Factories
Process capability
Building quality in versus reworking to the class 3 standard
Material supply chain
DFx
• DFP - BOM analysis
• DFM (Valor)
• DFT
– Extensive testing
• FPT / ICT
• Functional
• ESS / Thermal cycling
• Vibration
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Medical
Surgical Navigation Device
Wearable Defibrillator
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Medical
 Industry Specifications , Standards , and Certifications
– IPC-600, 610, 620, 7711/22
– ISO13485
– FDA registration ( Actual Assembler of Medical Device )
 Discipline requirement challenges
– No MRB authority
– IQ/OQ/PQ medical process validation and protocol critical
– Process locked (e.g., customer approval & validate submission )
– Foreign Object Debris (FOD) mitigation
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Medical
 Pros
– Attention Details
– Discipline Approach
– BOM, DWG, Test Specification , SW/HW, etc. information packages are electronic very
detailed
– Component traceability , Obsolescence, and Counterfeit
 Cons
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–
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Change is difficult (Product and Process)
Continuous improvement difficult
BOM, DWG, Test Specification , SW/HW, etc. information packages are cumbersome
Traceability adds to the overhead
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Military Aerospace
PCBA and Box build
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Military, Aerospace, Defense, and Space
 Industry Specifications , Standards , and Certifications
– IPC-600, 610, 620, 7711/22, J-STD-001ES
– AS9100, NADCAP (National Aerospace and Defense Contractors
Accreditation Program)
 Discipline requirement challenges
– No MRB authority
– Component obsolescence rampant
• Counterfeit mitigation important
– Environmental Testing Requirements
• ESS -45 to +85C @ 30C/min., Vibration 3-axis, etc.
– Conformal Coatings
– Foreign Object Debris (FOD) mitigation
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Military, Aerospace, Defense, and Space
 Pros
– Attention Details
– Discipline Approach
– BOM, DWG, Test Specification , SW/HW, etc. information packages are very
detailed
– Change is not as difficult
– Continuous improvement less of a problem
 Cons
– BOM, DWG, Test Specification , SW/HW, etc. information packages are
cumbersome
– Obsolescence, and Counterfeit
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Industrial
PCBA
Box build
Wire and Harness
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Industrial
 Industry Specifications , Standards , and Certifications
– IPC-600, 610, 620, 7711/22, J-STD-001
– ISO9001
 Discipline requirement challenges
– Component obsolescence minimal
• Counterfeit mitigation minimal
– Environmental Testing Requirements
• ESS -45 to +85C @ 30C/min., Vibration 3-axis, etc.
– Conformal Coatings
– Process is not locked (e.g., customer approval & validate submission )
– Foreign Object Debris (FOD) minimal
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Industrial
 Pros
– MRB authority granted
– Less Attention Details
– Discipline Approach Reduced
– Continuous improvement less of a problem
– Change is not as difficult
– Obsolescence, and Counterfeit is better
 Cons
– BOM, DWG, Test Specification , SW/HW, etc. information packages can be
incomplete
– Less testing can lead to escapes
– Inaccurate Doc packages can lead to mistakes
– Product changes are less formal
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
DRTL Overview
Dynamic Research and Testing Laboratories (DRTL)
 Component Risk Mitigation
 Destructive Physical Analysis
 Failure Analysis
 Product Qualifications
 Material Qualifications
 Consulting Services
 ISO 17025
Our staff offers highly respected technical expertise, personable
service, and quick response.
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
What are the chances of catching an escape?
100%
Probability of catching a sub-standard or counterfeit
part should one exist
High
95%
90%
85%
Medium
Economics
surrounding this level
of avoidance may not
be warranted
80%
75%
70%
65%
Low
60%
55%
50%
Level 1
Level 2
Level 3
Level 4
Level 5
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Optimized Case Recommendations ?

People are key

DFx

Process Improvement
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
Test
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
Focus
Continually monitor and improve your process
Reliability can not be “reworked in”
ICT, Vibration, ESS, Functional
Discipline requirements
– Allow MRB authority
– Common sense IQ/OQ/PQ medical validation process and protocol
– Component obsolescence & Counterfeit mitigation
– Environmental Testing Requirements
– Process is not locked / Allow continuous improvement
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Thank you!
Q&A ?
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission
Thank you!
Mark T. Talmadge
Director of Engineering Solutions
IEC Electronics Corp.
105 Norton St.
Newark, NY, 14513-0271
Phone: (315) 332-4460
Cell:(315)-374-3888
mtalmadg@iec-electronics.com
Mark R. Northrup
VP of Advanced Technical Operations and
Strategy
IEC Electronics Corp.
105 Norton St.
Newark, NY, 14513-0271
Phone: (315) 332-4283
Cell:(315)-573-2837
Mnorthru@IEC-Electronics.com
IEC Electronics Confidential – cannot be presented redistributed or shown to anyone without express written permission